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Biodentine Applicator (Gun)
SEPTODONT SAS SPECIALITES SEPTODONT · Model 01C0730 · UDI-DI 03701398108503
EJB
Prescription
8
510(k) clearances
39
Adverse events
1
Recalls
271
Facilities
Description
Device for extrusion of dentine substitute.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-05-09 | Biomet 3i, Inc. | The drill malfunctions while in use. The drill has been observed to become lodged in the handle. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.